CPCSEA Guidelines

CPCSEA Guidelines

1. CSJM University Kanpur University Institute of Pharmacy CPCSEA-”Committee for the purpose of control and supervision of experiments on animals” Presented By: Ruchi pal M. Pharm. (Pharmaceutics) 3 rd Sem.2019-20 Batch 1

2. CONTENTS Introduction IAEC Functions Goals Common laboratory animals GUIDELINES Veterinary care Quarantine Surveillance, Diagnosis, Treatment and control of disease Personal hygiene Environment Anesthesia Euthanasia Animal Husbandary Physical facilities Record keeping Standard operating procedure Personnel and training Transport of lab animals conclusion References 2

3. INTRODUCTION It is “ committee for the purpose of control and supervision of experiments on animals”. it is statutory body formed by the act of the Indian Parliament under the Prevention of cruelty to Animals Act,1960. The secretariat of CPCSEA has published its guidelines ,to ensure human and ethical treatment of animals, while carrying out legitimate scientific research. It was formed in 1964. The Animal Welfare Board of India (AWBI),headquartered at Ballabhgarh in Haryana state, is a statutory advisory body advising the Government of India’s Ministry of Fisheries, Animal Husbandry and Dairying (Department of Animal Husbandry and Dairying). Committee Members- It is composed of- Members of the scientific community. Regulatory authorities Animal activists The committee has 20 Experts and 03 official members. 3

4. IAEC-Institutional animal ethical committee- It is a body comprising of a group of persons recognized and registered by the CPCSEA. Function- Review and approve all types of protocols for research involving animal experimentation. Obtain the periodic reports on research development and shall ensure visit to animal house facility and laboratory . Ministry of environment & Forests (Animal welfare) 4 CPCSEA IAEC IBSC/IBC

5. Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions(IAEC). IAEC scrutinize all project proposals for experimentation on animals. For small animals-give the final approval. For large animals-make its recommendation to SCL(Sub-Committee on large Animals). 5

6. Functions of CPCSEA- Registration of establishments conducting animal experimentation or breeding of animals for this purpose. Selection and appointment of nominees in the institutional Animal ethics committees of registered establishments. Approval of animal house facilities on the basis of reports of inspections conducted by CPCSEA. Permission for conducting experiments involving use of animals. Recommendation for import of animals for use in experiments. Action against establishments in case of violation of any legal norm/stipulation. 6

7. GOALS- The goal of these guidelines is to promote the human care of animal used in biomedical and behavioral research and testing. To avoid unnecessary pain before, during & after experiments. Effective functioning of IAEC- To provide guidelines for- Housing, care, breeding & maintenance. Source of experimental animals. Acceptable experimental procedures for anesthesia & euthanasia. To provide quality in gaining advanced biological knowledge i.e , relevant to humans & animals. To provide specifications that will enhance animal well being. 7

8. COMMON LABORATORY ANIMALS MICE ( Mus musculus )- Life span:-1-3 years Weight:-male-20-30 gm Female-18-35 gm Birth weight:-1-2 gm Heart rate:-310-840 beats/min. Respiratory rate:-80-230 breaths/min. Body temperature:-36.5-38°C Blood volume:-1.5-2.5ml(58.5 ml/kg) Allergens:-Dander, Urinary protein 8

9. RABBIT ( Oryctolagaus cuniculus )- Life span:-8-12 years Weight:-1.2-2 kg Birth weight:-40-90 gm Heart rate:-310-325 beats/min. Respiratory rate:-30-60 breaths/min . Body temperature:-38.5-40 °C Blood volume:-57-65 ml/kg Allergens:-Dander, Urinary protein 9

10. RAT ( Rattus norvegicus )- Life span:-2.5 -3.5 years Weight:-male-300-500 gm Female-250-300 gm Birth weight:-5-6 gm Heart rate:-330-480 beats/min. Respiratory rate:-85 breaths/min. Body temperature:-35.9-37.5°C Blood volume:-50-70 ml/kg Allergens:-Dander, Urinary protein 10

11. GUIDELINES- VETERINARY CARE- Adequate veterinary care must be provided and is the responsibility of a veterinarian or a person who has training or experience in laboratory animal sciences and medicine. Observed regularly for sign of illness, injury or abnormal behavior.(Daily observation) Contagious disease-isolated from healthy animal. 11

12. QUARANTINE- Separation of newly received animals from those already in the facility until the health and possibly the microbial status of newly received animal have been determine. A minimum duration of quarantine- Small lab animals-1 week Larger animals-6 weeks An effective quarantine minimizes the chances for introduction of pathogens into an established colony. 12

13. SURVEILLANCE,DIAGNOSIS,TREATMENT AND CONTROL OF DISEASE- All animals should be observed for signs of illness, injury or abnormal behaviour by animal house staff. Animals that show signs of a contagious disease should be isolated from healthy animals in the colony. Unexpected deaths and signs of illness should be reported. Diagnostic clinical laboratory may be made available. 13

14. PERSONAL HYGIENE- It is essential that the animal care staff maintain a high standard of personal cleanliness. Clothing suitable for use in the animal facility should be supplied and laundered by the institution. It acceptable to use disposable gear such as gloves, masks, head covers, coats, coveralls & shoe covers. Person should change clothing as often as is necessary to maintain personal hygiene. Personnel should not be permitted to eat, drink, smoke or apply cosmetic in animal rooms. 14

15. ENVIRONMENT- AIR CONDITIONING is for laboratory animals temperature with in the range of 18-29 o C. RELATIVE HUMIDITY -30-70% throughout the year for large animal comfortable zone. POWER & LIGHTING -The electrical system should be safe and provide appropriate lighting and a sufficient no. of power outlets. A time control light system should be used. NOISE CONTROL -Noise free environment. 15

16. ANESTHESIA- It must also be ensured that the anesthesia is given for the full duration of experiment and at no stage the animal is conscious to perceive pain during the experiment. Sedative ,analgesics and anesthetics should be used to control pain or distress under experiment. 16

17. EUTHANASIA- Purpose- End of experiment, to provide tissue foe scientific purpose. Free the animal from pain. Diseased animal or animal in bad condition. Death without causing anxiety, pain or distress with minimum time lag phase. Minimum physiological and psychological disturbances. Compatibility with the purpose of study and minimum emotional effect on the operator. Location should be separate from animal rooms and free from environmental contaminants. 17

18. ANIMAL HUSBANDRY- (CAGING & HOUSING SYSTEM) Adequate ventilation. Meet the biological need of animal. Keep the animal dry & clean. Cages made of steel or painted steel. Feeding and watering devices should be easily accessible for filling, changing, cleaning and servicing. FOOD- Should be fed palatable ,non-contaminated and nutritionally adequate food. Diet should be free from heavy metals. 18

19. BEDDING- Absorbent, free of toxic chemicals or other substances that could injure animals or personnel. Should be removed and replaced with fresh materials as often as necessary to keep animals clean & dry. WATER- Ordinarily animals should have continuous access to fresh, potable, uncontaminated drinking water according to their particular requirements. WASTE DISPOSAL- Wastes should be removed regularly and frequently. All waste should be collected and disposed in a safe and sanitory manner. The most preferred method of waste disposal is incineration. EMERGENCY,WEEKEND & HOLIDAY CARE- Animal should be cared for by qualified personnel everyday, including weekends and holidays, to safeguards their well-being including emergency veterinary care. 19

20. PHYSICAL FACILITIES- BUILDING MATERIALS- Moisture proof ,fire-resistant, seamless materials are most desirable for interior surfaces including vermin and pest resistance. CORRIDOR- Wide enough to facilitate the movement of personnel as well as equipment & should be kept clean. UTILITIES- Water lines, drain pipes & electrical connection. ANIMAL ROOM DOORS- Rust, vermin & dust proof.it is properly within their frames and provided with an observation window. FLOORS- Smooth, moisture proof, non-absorbent, skid-proof. DRAINS- Floor drains are not essential in all rooms used exclusively for housing rodents. WALL & CEILINGS- Free of cracks, unsealed utility penetration or imperfect function with doors, ceilings, floors and corners. 20

21. STORAGE AREAS- Separate storage areas should be designed for feed, bedding, cages & materials not in use. FACILITIES FOR SANITIZING EQUIPEMENT AND SUPPLIES- An area for sanitizing cages and ancillary equipment is essential with adequate water supply. EXPERIMENTAL AREA- Separate area from the place where animals are housed. POWER & LIGHTING- Lighting system must be installed that provides adequate illumination while people are working in the animal rooms and a lowered intensity of light for the animals, for e.g , Fluorescent lights. 21

22. RECORD KEEPING- The animal house should maintain following records- Animal house plans, which includes typical floor plan, all fixtures etc. Animal house staff record both- technical & non-technical. Health record of staff animals. All SOPs relevant to the animals. Breeding, stock, purchase and sales records. Minute of institute animals ethics committee meetings. Records of experiments conducted with the number of animals used. Death records . Clinical record of sick animals. Training record of staff involved. 22

23. STANDARD OPERATING PROCEDURE- Maintain standard operating procedure (SOP) describing procedures/methods adapted with regard to animal husbandry, maintenance, breeding, animal house microbial analysis and experimentation record. SOP should contain following items:- Name of author Title of SOP Date of preparation Reference of previous SOP on the same subject & date. Location and distribution of SOPs with sign of each recipient. Objectives Detailed information of the instruments used in relation with animals. Normal value of all parameters. 23

24. PERSONNEL AND TRAINING- The selection of animals facility staff, particularly the staff working in animal rooms or involved in transportation ,is a critical component in the management of an animal facility. The staff must be provided with all required protective clothing (masking, aprons, gloves , gumboots and other footwear) while working in animal rooms. Facilities should be provided for change over with lockers, wash basin, toilets and bathrooms to maintain personal hygiene. Regular medical check-up is arranged for the workers. Persons working in animal house do not eat, drink, smoke in animal room and have all required vaccination. Initial in-house trainings of staff at all levels is essential. 24

25. TRANSPORT OF LAB ANIMALS- The main considerations for transport of animals are- The mode of transport. The containers. The animals density in cages. Food and water during transit. Protection from transit infection, injuries and stress. 25

26. CONCLUSION Animal should be handled with extreme care at every step of experiment . Unnecessary animal killing should not be practiced. Laboratory animals should be used only for learning and research objectives. Euthanasia shall be preferred if animal is suffering from uncontrollable paining sensations & severe organ failures. Always perform experiment in presence of expertise of animal handling, with the use an anaesthetic agent to reduce the paining sensations. 26

27. REFERENCES Kulkarni S.k , common laboratory animals(1999)”Handbook of experimental pharmacology”, Vallabh prakashan , Delhi. page no.11-18. CPCSEA guidelines for laboratory animal facility, Indian journal of pharmacology 2003;35;page no.257-274. Subramanian A, Gitanjali B,CPCSEA-A double edged sword, Indian Journal of pharmacology 2003;page no.71-72. http://cpcsea.nic.in/content/55-1-guidelines.aspx . Derelanko MJ, The toxicologist’s pocket handbook. CRC Press;2017 Nov.6. 27

28. THANK YOU “BE KIND TO EVERY KIND,NOT JUST MANKIND.” 28